Patty Leahy
Bloomington,IN
Summary
In-depth Quality Assurance Specialist with success in prioritization and multitasking. Exceptional communication and organizational skills. Committed to paying impeccable attention to reviews and auditing procedures.
Overview
22
22
years of professional experience
Work History
Senior Quality Representative
Catalent
02.2021 - Current
- Review/Disposition of Manufacturing, Formulation and Packaging Master Batch Records
- Follow cGMP, GDP, SOP’s, and WI’s during review of the Master Batch Records
- Assist Operators in correcting GDP errors
- Open Deviations found during Batch Record Review, in Trackwise
- Operate various computer software; JDE (inventory system) Trackwise, Word, Excel, PowerPoint, and multiple SharePoint sites
- Works with both internal and external client teams to ensure consistent communication of clinical trial material supply status for clinical trial batches
- Utilizes sponsor documentation methods, practices, and policies, as required, that are in conjunction with, but do not contradict Catalent Standard Operating Procedures
- Stays abreast of relevant cGMPs, GDPs, and other regulatory requirements and ensures study management activities are aligned with batch record requirements
- Attend client-related meetings and appropriately represent status of Clinical trial Batch Record status.
- Maintained an up-to-date knowledge of industry trends, emerging technologies, and best practices in quality management, sharing insights with colleagues to foster professional growth.
- Collaborated with cross-functional teams to develop corrective actions for identified non-conformances, resulting in improved overall quality metrics.
Quality Representative
ThermoFisher Scientific
07.2014 - 02.2021
- Review/Audit of Pre-Approvals for Manufacturing and Packaging of Electronic Production Orders
- Review/Audit of Post Approvals for Manufacturing and Packaging of Electronic Production Orders
- Ensure adequate document control for manufacturing and packaging instructions and cGMP Standard Operating Procedures
- Assemble and create document packets for Production Orders
- Reviewed and approved study protocols
- Submit requests for any Deviations found during Batch Record Review
- Assisted Operators in correcting of GDP errors
- Approval of CAPA’s, Effectiveness Checks, and Change Controls within Trackwise
- Operate various computer software; Success Factors, Trackwise, GPM, Word, Excel, PowerPoint, and SharePoint
- Participate and aid during external audits (mainly back room support)
- Demonstrate and drive the ThermoFisher values – Integrity, Intensity, Involvement and Innovation (The Four I’s)
- Backup support for the Training Program including adding training assignments in Success Factors
- Review and tracking of facility Logbooks ensuring reviews and corrections were completed per Standard Operating Procedures
- Revising of SOP’s, JA, WI, and forms within the eDMS system to ensure compliance
- Traveling to other sites to support Batch Review as needed.
- Ensured compliance to industry standards, conducting regular audits and maintaining documentation.
Quality Assurance Analyst I
Baxter Pharmaceutical Solutions
01.2002 - 01.2014
- Review/Release of various Master Batch Records within assigned due dates
- (Aseptic Formulation, Filling, and Packaging.) Identify and track documentation errors in order to reduce errors
- Assisting clients in understanding of batch processing
- Review of Autoclave Cycles/Strip and Circular charts
- Run Queries in Trackwise during review and release of MBR’s
- Update Gemba boards and attend Tier III’s
- Review of Temperature Charts for the Warehouse and Coolers
- Identify and initiate deviations within the Trackwise System
- Complete CAPA’s within assigned due dates
- Participated on teams to complete Process Flows and Kaizen Events
- Participated in implementation of new Building processes
- Participated in a JDE process improvement process.
Quality Assurance Documentation Coordinator
Baxter Pharmaceutical Solutions
01.2008 - 01.2011
- Process, ship, and maintain retention of Batch Records
- Computer proficient (Microsoft, Trackwise, JDE, and Qumas.) Maintain a team environment in order to meet client demand
- Provide excellent customer service in relation to client requests
- Conduct initial Batch Record review to expedite batch release
- Provided key assistance in the implementation of the new Doc
- Center Review of Logbooks assigned to the Quality Group.
Education
Bachelors of Science in Business -
Indiana Wesleyan University
Marion, INSkills
- Quality assurance expertise
- ISO standards knowledge
- Documentation Review
- Quality Management Systems
- Continuous improvement strategies
Timeline
Senior Quality Representative
Catalent
02.2021 - Current
Quality Representative
ThermoFisher Scientific
07.2014 - 02.2021
Quality Assurance Documentation Coordinator
Baxter Pharmaceutical Solutions
01.2008 - 01.2011
Quality Assurance Analyst I
Baxter Pharmaceutical Solutions
01.2002 - 01.2014
Bachelors of Science in Business -
Indiana Wesleyan University
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